JYE — Chisel, Middle-Ear Class I
FDA product code JYE covers "Chisel, Middle-Ear", a Class I medical device regulated under 21 CFR 874.4420. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- JYE
- Device Class
- Class I
- Regulation Number
- 874.4420
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K822165 | kelleher | ENT CHISELS | August 16, 1982 |